Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusion

Indonesia is one of country that contributes the most cases of tuberculosis worldwide. Tuberculosis is the most commonly etiology of exudative pleural effusion. There have been many studies about undiagnosed exudative pleural effusion, but there are not many studies about the use of medical thoracoscopy for diagnosing transudative and exudative pleural effusion, especially on biomarkers of C-Reactive Protein (CRP), D-dimer, Adenosine Deaminase (ADA), Antinuclear Antibody (ANA), C3 C4 complements, Cancer Antigen 125 (CA-125), Xpert Mycobacterium Tuberculosis (Xpert MTB), Lupus Erythematosus cell (LE cell), cytology (effusion and smear) and histopathology. Information gained from those biomarkers via thoracenthesis and medical troracoscopy, etiology of exudative and transudative pleural effusion can be detected earlier and clearly, especially etiology of infection, autoimmune, and malignancy that further can be used to reduce patients' hospitalization period, mortality, and to develop the new therapeutic agents.

Study Overview

• Status: Recruiting
• Conditions: Medical Thoracoscopy
• Intervention / Treatment: Procedure: Medical thoracoscopy

Detailed Description

Medical thoracoscopy is a minimally invasive procedure to access pleura with combination of visual and medical instrument. The procedure is performed under local anesthesia and conscious sedation. Medical thoracoscopy plays role in basic diagnotic and therapeutic. The most common indication on basic diagnostic is on pleural effusion case that has primary target to get specific diagnosis when the etiology of pleural effusion is unknown. Pleural effusion is fluid accumulation inside the pleura for about 15-20 ml. Primary aim of pleural effusion diagnosis is to differentiate exudative and transudative effusions based on Light Criteria. Most of time thoracentesis cannot give etiology of exudative and transudative pleural effusion.

Researchers will evaluate subjects based on inclusion and exclusion criteria in Cipto Mangunkusumo Hospital. Furtehrmore, research subjects will be asked for informed consent. Data will be collected based on research form. Researcher will perform medical thoracoscopy to take specimen for analysing CRP, D-dimer, ADA, ANA, C3 C4 complements, Xpert MTB, LE cell, cytology (effusion and smear) and histopathology to detect the etiology of tuberculosis, malignancy or autoimmune.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gurmeet Singh, MD, PhD; Phone Number: +6281385158159; Email: gurmeetsingh10@yahoo.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Recruiting
      • Cipto Mangunkusumo Hospital
      • Contact: Gurmeet Singh, MD, PhD; Phone Number: +6281385158159; Email: gurmeetsingh10@yahoo.com
      • Contact: Rizki Triono, MD; Phone Number: +6281293329000; Email: m.rizkitriono@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hospitalized adult age 18 - 75 years old
• Willing to be involved in the research
• Undiagnosed transudative and exudative pleural effusion post-thoracentesis twice on right and left lung
• Patients can undergo medical thoracoscopy under local anesthesia, based on ATS and BTS guideline

Exclusion Criteria:

• Pregnant and breastfeeding women
• Patients in non-invasive ventilation and mechanical ventilator
• Transudative and exudative pleural effusion with etiology of chronic heart failure, chronic kidney disease, hepatocirrhosis with or without hepatic hydrothorax and hypoalbuminemia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: undiagnosed transudative and exudative pleural effusion; Subjects with undiagnosed transudative and exudative pleural effusion will undergo medical thoracoscopy as per studies protocols.

Procedure: Medical thoracoscopy; Medical thoracoscopy is a minimally invasive procedure to have access to pleura with combination of visual and medical instrument. The procedure is done with local and light anesthesia. Medical thoracoscopy plays role in basic diagnosis and therapeutic. A Flex-rigid thoracoscope will be inserted through the trocar cannula in the rigt or left mid axillary line of the hemithorax; Other Names: Flex-rigid thoracoscope via trocar cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To analyze role of medical thoracoscopy on undiagnosed transudative and exudative pleural effusion patients	To investigate whether medical thoracoscopy has a high diagnostic yield in undiagnosed transudative and exudative pleural effusion patients	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To know the prevalency of undiagnosed transudative and exudative pleural effusion.	Number of subjects with undiagnosed transudative and exudative pleural effusion will be assessed through medical thoracoscopy	Up to 12 months
To know the etiology of infection, autoimmune and malignancy on undiagnosed transudative and exudative pleural effusion	Number of subjects with undiagnosed transudative and exudative pleural effusion will be classified for etiology of infection, autoimmune and malignancy at 2 weeks	2 weeks
To analyze biomarkers from blood (CRP, D-dimer, ANA, C3 C4 complements, CA-125) , , cytology (effusion and smear) and histopathology on undiagnoses transudative and exudative pleural effusion	Results of CRP, D-dimer, ANA, C3 C4 complements, CA-125 from blood samples from subjects with undiagnosed transudative and exudative pleural effusion will be known at 12 months	Up to 12 months
To analyze biomarkers from pleural effusion (ADA, Xpert MTB, LE cell)	Results of ADA, Xpert MTB, LE cell from pleural effusion samples from subjects with undiagnosed transudative and exudative pleural effusion will be known at 12 months	Up to 12 months
To analyze cytology (effusion and smear) and histopathology on undiagnosed transudative and exudative pleural effusion	Results of cytology and histopathology from subjects with undiagnosed transudative and exudative pleural effusion will be known at 12 months	Up to 12 months

Collaborators and Investigators

• Sponsor: Dr Cipto Mangunkusumo General Hospital
• Collaborators: Singapore General Hospital
• Investigators: Principal Investigator: Gurmeet Singh, MD, Phd, Cipto Mangunkusumo Hospital

Publications and helpful links

General Publications

• Light RW. Clinical practice. Pleural effusion. N Engl J Med. 2002 Jun 20;346(25):1971-7. doi: 10.1056/NEJMcp010731. No abstract available.
• Rodriguez-Panadero F, Janssen JP, Astoul P. Thoracoscopy: general overview and place in the diagnosis and management of pleural effusion. Eur Respir J. 2006 Aug;28(2):409-22. doi: 10.1183/09031936.06.00013706. No abstract available.
• Ferreiro L, Toubes ME, San Jose ME, Suarez-Antelo J, Golpe A, Valdes L. Advances in pleural effusion diagnostics. Expert Rev Respir Med. 2020 Jan;14(1):51-66. doi: 10.1080/17476348.2020.1684266. Epub 2019 Nov 5.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): April 15, 2024
• Study Completion (Estimated): May 15, 2024

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: 1111/UN2.RST/HKP.05.00/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No